The Toxic Substances Control Act (TSCA), enacted in 1976, is a key law for regulating toxic substances in the United States.
The TSCA authorizes the Environmental Protection Agency (EPA) to study the health and environmental effects of chemicals already on the market and new chemicals proposed for commercial manufacture. If the EPA finds these health and environmental effects to pose unreasonable risks, it can regulate, or even ban, the chemical(s) under consideration.
The initiative to regulate toxic substances began in the early 1970s. In 1971, the Council on Environmental Quality produced a report on toxic substances. It concluded that existing health and environmental laws were not adequately regulating such substances. The report recommended that a new comprehensive law to deal with toxic substances be enacted. Among the problem substances that had helped to focus national concern on toxic substances were asbestos, chlorofluorocarbons (CFCs), Kepone (a pesticide), mercury, polychlorinated biphenyls (PCBs), and vinyl chloride. Research proved that these substances caused significant health and environmental problems, yet they were unregulated.
The approach adopted in TSCA is premarket notification, rather than the more rigorous premarket testing that is required before new drugs are introduced on the market. When a new chemical is to be manufactured or an existing chemical is to be used in a substantially different way, the manufacturer of the chemical must provide the EPA with premanufacture notification data at least 90 days before the chemical is to be commercially produced. The EPA then examines this data and determines if regulation is necessary for the new chemical or new use of an existing chemical. The agency can require additional testing by manufacturers if it deems the existing data insufficient. Until such data are available, the EPA has the option to ban or limit the manufacture, distribution, use, or disposal of the chemical. For new chemicals or new applications of existing chemicals, producers must demonstrate that the chemicals do not pose unreasonable risks to humans or the environment. The EPA can act quickly and with limited burden to prevent such new chemicals from being produced or distributed.
Between July 1979, when TSCA went into effect for new chemicals, and April 2002, the EPA received 23,486 new chemical notices. The agency determined that no action was necessary for nearly 90% of these chemicals. Of the 2,702 chemicals that required further action, 917 were never produced commercially due to EPA concerns. The remaining 1,785 chemicals were controlled through formal actions or negotiated agreements.
There were over 83,000 chemicals within the purview of TSCA. Although the law requires that the EPA examine each of these chemicals for its potential health and environmental risk, the volume of chemicals and lack of EPA resources has made such a task virtually impossible. Through 2000, the agency had examined almost 700 existing chemicals. Of the compounds on this list, the EPA determined that 370 chemicals required no further action. This was due to the fact that the chemical was no longer being manufactured, it was under study by another federal agency or industry, adequate data on the chemical existed, or exposure to the chemical was limited. The EPA issued rules to regulate 112 of these chemicals. The remaining chemicals were in various stages of testing and review.
TSCA created an Interagency Testing Committee (ITC) to help the EPA set priorities. The ITC designates which existing chemicals should be examined first. Once designated by the ITC, the EPA has one year to study the chemical and issue a ruling. The agency initially had difficulty meeting this one-year limit. In fact, the EPA was sued over its failure to meet the deadline and worked under a court schedule to test these identified chemicals. The record of the EPA has improved, but the agency continued to struggle to meet deadlines imposed by ITC due to budgetary and personnel shortages.
The EPA also identifies specific chemicals already in use for review. Unlike the policy with new chemicals, the EPA must demonstrate that existing chemicals warrant toxicity testing. Furthermore, if the EPA desires to regulate the chemical once it has been tested, it must pursue another complex course of action. By design, the regulation of existing chemicals is a lengthy and complicated process.
There are several options available to the EPA if it concludes that a new or existing chemical presents “an unreasonable risk of injury to health or the environment.” The EPA can 1) prohibit the manufacture of the chemical by applying a rule or obtaining a court injunction; 2) limit the amount of the chemical produced or the concentration at which the chemical is used; 3) impose a ban or limit uses of the chemical; 4) regulate the disposal of the chemical; 5) require public notification of its use; and 6) require labeling and record keeping for the chemical. The EPA is required to use the least burdensome of these regulatory approaches for chemicals already in use.
There are several other important components to TSCA. First, the law requires strict reporting and record keeping by the manufacturers and processors of the chemicals regulated under the law. In addition to keeping track of the chemicals, these records include data on environmental and health effects. Second, TSCA is one of the few federal environmental laws that require environmental and health benefits to be balanced by economic and societal costs in the regulatory process. The act states that toxic substances should only be regulated when an unreasonable risk to people or the environment is present. Although “unreasonable risk” is not clearly defined in the language of the act, it does incorporate a concern for balancing costs and benefits.
Fourth, TSCA contained provisions for private citizens, as opposed to the U.S. government, to file lawsuits. Under the TSCA rules, private citizens could sue companies for violation of the law. They could also sue the EPA for failure to implement TSCA in a timely manner. Fifth, certain materials are not covered by TSCA. These include ammunition and firearms; nuclear materials; tobacco; and chemicals used exclusively in cosmetics, drugs, food and food additives, and pesticides. These substances are regulated by other laws.
The scope of the law was expanded in 1986 by an amendment requiring asbestos hazards to be reduced in schools and in 1988 by an amendment providing grants and technical assistance to state programs that reduce indoor radon and assigning the regulation of genetically engineered organisms to TSCA. A 1990 amendment required accreditation of persons who inspect for asbestos-containing material in school, public, and commercial buildings, and the Residential Lead-Based Paint Hazard Reduction Act of 1992 introduced new requirements for the reduction of hazards associated with the inspection and abatement of lead-based paints.
In terms of existing chemicals, only one—PCBs—has been banned in the United States. Many chemicals in pesticides have been heavily regulated. A notable EPA action was prohibiting the use of chlorofluorocarbons (CFCs) as aerosol propellants. This occurred in March 1978.
Lack of action may be due in part to the costs involved in implementing such a complex regulatory program. It is also difficult to determine unreasonable risk in light of inadequate data and more general uncertainties. Most premarket notifications for new chemicals are not accompanied by test data. Rather, the EPA identifies potentially harmful chemicals by comparing the new chemical to existing chemicals for which data exists. If the EPA were to require more data for most new chemicals, in many cases the new chemicals might not be produced since the test costs would exceed the expected profit.
The chemical industry and environmentalists have reached conflicting conclusions about the TSCA legislation. The chemical industry has argued that the EPA has required more testing than is scientifically needed and that the regulatory approach for new chemicals is overly burdensome. Environmentalists have criticized the EPA for its slow progress in examining existing chemicals, for requiring no health data for new chemicals, and for withholding much of the data for new chemicals to comply with the desire for confidentiality requested by chemical manufacturers.
See also Asbestos ; Chemical poisoning ; Environmental Protection Agency (EPA) ; Insecticide poisoning ; Lead ; Mercury ; Radon .
Applegate, John, et al. The Regulation of Toxic Substances and Hazardous Wastes. 2nd ed. New York: Foundation Press, 2011.
Kumar, Dharti. Nanomaterials: Toxicity, Health and Environmental Issues. Weinheim, Germany: Wiley-VCH, 2006.
U.S. Environmental Protection Agency. “Human Health: Toxicity.” http://www.epa.gov/ebtpages/humatoxicity.html (accessed October 25, 2010).
U.S. Environmental Protection Agency. “Learn the Issues: Pesticides, Chemicals and Toxics.” July 10, 2012. http://www.epa.gov/gateway/learn/pestchemtox.html (accessed August 13, 2012).
World Health Organization. “Intergovernmental Forum on Chemical Safety.” WHO Programs and Projects. http://www.who.int/entity/ifcs/en (accessed August 13, 2012).
L. Fleming Fallon, Jr, MD, DrPH
Revised by Stacey Chamberlin